Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma

Research summary

Leiomyosarcoma (LMS) is a type of rare cancer that grows in the smooth muscle tissue. The prognosis for patients with metastatic LMS (cancer that has spread to other parts of the body) is poor, and there are few effective treatments available. In previous clinical studies, LMS patients were treated with lurbinectedin in combination with doxorubicin. Lurbinectedin is an experimental medication that has been shown to kill cancer cells and modify the environment around the tumour to block growth. Doxorubicin is an approved anti-tumour medication that kills cancer cells or stop the growth of cancer cells. Findings from previous studies show that treatment with lurbinectedin in combination with doxorubicin showed some benefit in LMS patients. The benefits observed were a reduction in tumour size and/or no worsening of disease. Based on the previous results, the hypothesis is that lurbinectedin in combination with doxorubicin is more effective than doxorubicin alone for the treatment of metastatic LMS in patients that have not previously received treatment with doxorubicin or other therapies for advanced cancer. The purpose of this study is test the effectiveness and safety of lurbinectedin in combination with doxorubicin compared to doxorubicin alone in patients with metastatic LMS. The study is split into parts, Phase II b and Phase III. The aim of the study is to find the ideal dosing regimen of the study medications, and to test the study medications in a larger number of LMS patients to verify the findings from previous studies. It is expected that the study will last 40 months, and approximately 240 participants are expected to take part. This study is a first-line treatment for LMS patients, so only patients that have not received previous systemic therapy for their cancer are eligible to participate. The study includes a Screening period, a Treatment period and a Follow-up period lasting in total approximately 15 months for each participant. In the treatment period, participants will either receive lurbinectedin in combination with doxorubicin or doxorubicin alone, once every 3 weeks. Treatment will be administered intravenously on Day 1 of each cycle at study site. Additionally, participants will also receive supportive medication to help manage the side effects of treatment. At the end of the treatment period, participants will complete an end of study visit. Participants of this research study will also be invited to a pharmacogenomic sub-study detailed on page 81 of the protocol.

Principal Investigator

Dr Sarah Pratap

Contact us

Email: latephaseoncology@ouh.nhs.uk

IRAS number

1007801